Prefilled syringe



A ril 2, 1968 G. H. KELLER PREFILLED SYRINGE Filed Sept. 2, 1965 2Sheets-Sheet 1 IN VENTOR. 4/5; A f ,6

4 94,, p V MM G. H. KELLER April 2, 1968 PREFILLED SYRINGE 2Sheets-Sheet 3 Filed Sept. 2, 1965 United States Patent 1 O ABSTRACT OFDISCLOSURE A prefilled syringe assembly having a barrel portionfor'containing medicament. A stopper which may be coupled to a plungerrod seals the rear end of the barrel and a diaphragm seals the forwardend. A cap is mounted on the forward end of the barrel to maintain thediaphragm in sealing engagement with the barrel. The forward portion ofthe cap forms a support to receive the hub support cooperate indetermining the position of the cannula relative to the barrel anddiaphragm. A cannula shield protects the forward penetrating end of theneedle and is mounted on the hub in a manner to facilitate arming of thesyringe and also may be removed from the hub and coupled with thestopper to act as a plunger rod.

This application is a continuation-in-part of my earlier filedapplication Ser. No. 425,786, filed Jan. 15, 1965.

It istherefore a principal object of this invention to provide animproved prefilled syringe construction of the type disclosed in theaforementioned pending patent application as well as a constructionrequiring a minimum number of parts, each individually simple tomanufacture and assemble, therefore reducing the overall cost of thesyringe. i

A prefilled syringe assembly in accordance with. this invention includesa syringebarrel for containing the desired medicament. The rear endofthe interior of the barrel is sealed by means of a stopper provided withstructure forcoupling with a plunger rod. The forward end of the barrelinterior is sealed by means of a diaphragm. A cap is adapted to bemounted on the forward end of the barrel for maintaining. the diaphragmseal in this sealing relationship. This cap isprovided with an integralof support at its forward end for receiving the hub of a cannulahubassembly. Cooperating surfaces of the cannula and hub support determinethe farmed? and unarmed position of the syringe at which the inner endof a double bevel ended hypodermic cannula-has penetrated the diaphragmseal to communicate its lumenwith the barrel interior and at a positionat which the inner end of the cannula is spaced from the diaphragm andpoised to be inserted therethrough, respectively, A cannula shieldprotects the forward mounted on the cannula hub ina manner to facilitatearming of thensyringet'The shield also serves the dual purposeof. beingav plunger rod having structure adapted to be' coupled with that of thestopper upon removal from the cannula may also incorporate structurethat facilitates gas sterilization and structure capable of beingprepackaged in the manner disclosed in my earlier aforementioned pendingpatent application. i a I i Other objects and advantages willv becomeapparent from the following detaileddescription which is to be taken inconjunction with the accompanying drawings illustrating a somewhatpreferred embodiment of this invention and in which: 7

FIG. 1 is a side elevational view of a prepackaged penetrating end oftheneedle and is i hub. The syringeassembly of this invention 3,375,825Patented Apr. 2, 1968 syringe incorporating the teachings of the presentinvention;

FIG. 21's anexploded elevational view thereof;

FIG. 3 is a longitudinal sectional view thereof along the line 3-3 ofFIG. 1;

FIG. 4 is a somewhat similar longitudinal sectional view showing thesyringe in an armed position ready to use at which the plunger rodshield is coupled with the stopper in the barrel;

FIG. 5 is an enlarged elevational view partly in section showing theinterior construction of the cap which is adaptedlto be coupled with theforward end of the syringe barrel;

FIG. 6 is a top plan view of the cap;

FIG. 7 is an enlarged fragmentary sectional view showing the dispositionof parts of the syringe while unarmed and poised ready for penetrationof the diaphragm seal; and

FIG. 8 is a similar view showing the disposition of parts upon arming ofthe syringe with the inner end of the cannula penetrating the diaphragm.

In the drawings, a prefilled syringe 20 is shown in assembled conditioncontaining a medicament or other preparation which, in a number ofcontemplated applications is preferably out of contact with thetypically employed stainless steel hypodermic cannula. The medicament isadapted to be contained in a barrel 22 having a rear flanged end 24 anda forward reduced tip 26 having a flanged end 28 and innergroove 30. Therear end of the interior of the barrel 22 is adapted to be sealed orclosed by means of a stopper 32 which may have one of a number offittings similar to the internal threads 34 for coupling with matingthreads of a plunger rod shield 36. As will be appreciated, the barrel22 with stopper 32 mounted in place may aseptically be filled. with theselected medicament through the relatively wide mouth of the tip 26following sterilization. The sterile forward end of the assembly maythen be aseptically assembled on the tip 26 in a manner to be described.

The forward end of the syringe barrel 22 is sealed by a penetrablediaphragm seal 36. This diaphragm is effective in sealing off the boreof the tip and is adapted to be penetrated by the inner end of a doubleended needle or cannula for purposes of providing access to this boreand consequently the contents of the barrel. A cap 38 of plasticmaterial cooperates with the tip 26 of the barrel in securing thediaphragm seal 36 thereto. In accordance with a successful embodiment ofthis invention, the cap 38 was fabricated of Celcon resin which isessentially composed of ethyl cellulose and plasticizers. The cap 38includes a radially extending flange portion 40 having an internal faceadapted to be associated directly with the forward face of thediaphragmseal 36. A radial rib 42 is provided on the exterior of the tubularcannula hub supporting portion 44 for cooperating with surfaces of thecannula hub in determining the syringe .unarmedf and armed positions.The cap 3.8 is also provided with an integral ferrule portion-46 whichis adapted ,to secure the cap 38 together with the diaphragm seal 36 tothe barrel tip 26. In this connection an annularinwardly extendingrib48is adapted to be forced over the flange 28 at the tip 26 as a resultof the inherent elasticity of the: plastic material employed forfabricating the cap 38. This movement is facilitated bythe rearwardbevelled face 50 of the rib 48 which in elfect produces a cammingaction. The forward face 52 of the rib 48 is, however, substan tiallynormal to the longitudinal axis of the cap and thereby provides arelatively firm surface-to-surface engagement with the rear face of theflange 28 for purposes of securely anchoring the cap thereto, Therear'end of the ferrule portion 46 is providedwith a seriesoftuniformlyspaced longitudinal notches 54 which not only facilitates the mountingof the cap 38 on the barrel tip 26 but also serves to stabilize the cap38 thereon by resiliently engaging with the radially outwardly extendingsurface 56 at the forward end of the barrel 22.

The longitudinally extending space slots 54 not only serve to stabilizethe cap against rocking or lateral movement but at the same time providesome degree of tolerance between the cap and syringe barrel whereby thedesired concentrated line contact can be obtained between the rib 80 andthe diaphragm seal 36. In this manner the cap 38 is effective inmounting the diaphragm seal 36 and the hypodermic needle assembly to thereduced forward tip of a barrel fabricated of glass. As mentioned in myearlier filed application, the exterior tolerances of such glass tipsare difficult to maintain within acceptable ranges and in a number ofinstances a wobbly association typical of prior art assemblies hasdetracted both structurally and functionally from acceptable syringeconstruction.

With the use of a plastic cap 38 it is extremely desirable to obtain,maintain and assure an optimum and adequate seal between the diaphragmseal 36 and the barrel tip 26. With this in mind the present inventionprovides for ribbing 80 on the inner face of the flange 40 of the cap38. This ribbing is preferably in annular form and as close to the capaxis as possible and at the same time preferably possesses a radiussmaller than that of the bore through the tip 28 of the barrel. Thisribbing operates to concentrate the pressure exerted by the cap 38 onthe seal 36 and in turn the seal 36 on the tip 26. By eating the ribbingas close to the axis as possible while within the confines of the boreof the tip 26 the effect of cocking or tilting of the assembly supportedby the barrel tip 26 will be minimized. In other words, if wobblingoccurs and pressure relieved due to this action, the concentratedpressure points will operate to maintain the desired seal between seal36 and barrel tip 26.

A hypodermic needle or cannula assembly 60 having particular applicationalong with this invention comprises a cannula 62 having a forwardbevelled penetrating end 64 and a rear bevelled penetrating end 66. Thiscannula 52 is secured to a hub 68. A number of strategically locatedrecesses 60 for receiving a suitable adhesive having bonding affinityfor the cannula 62 serves to facilitate the securement both throughbonding and the mechanical interlock of this construction. An epoxybonding system has .proven satisfactory particularly in those instanceswhen a stainless steel cannula 62 is employed. The forward end 72 of thehub 68 is in the form of a reduced boss providing a surface comparablewith the plunger rod shield 34, as shown. The rear end of the hub 68 isopen and is adapted to advantageously fit over the forward tubularportion 44 of the top 38. A pair of spaced annular accommodating grooves76 and 78 in the hub 68 are adapted to receive the radial rib 42 incooperation therewith for purposes of determining the desired forwardextreme of the needle assembly 60 at which the inner penetrating end 66of the cannula is poised for penetration of the diaphragm 36 and theinner penetrating position at which the inner bevelled end 66 penetratesthe diaphragm 36 to thereby expose the contents of the barrel 22 forinjection purposes. This rib and groove arrangement defines the unarmedand armed positions respectively. A positive position for the armedcondition facilitates shield removal and minimizes the possibility ofunarming an armed syringe. The inherent resiliency and elasticity of thesynthetic organic resins from which the hub 68 is ordinarily fabricatedwill permit this form of cooperating structure.

With respect to the filling and sterilization and packaging of thesyringe of this invention, reference should be made to myabove-mentioned earlier filed pending patent application.

Although a single somewhat preferred embodiment of this invention hasbeen disclosed and described in detail herein, it should be understoodthat this invention is in no sense limited thereby and its scope is tobe taken by that of the appended claims.

I claim:

1. A prepackaged syringe assembly comprising a tubular barrel containinga medicament and having a forward transversely extending shoulder andhaving a restricted forward flanged end extending from the shoulder andrear end, a stopper closing the rear end of the barrel, a penetrablediaphragm sealing the forward end of the barrel resilient cap means forsupporting a needle and securing the diaphragm to the barrel flangedforward end including a needle hub support of tubular configuration anda ferrule portion integral therewith for securing the diaphragm to thebarrel flanged forward end, the ferrule portion having an integralradially inwardly extending annular rib adapted to engage with surfacesof the flange end of said barrel to thereby affix said cap meansthereto, said ferrule portion having a series of spaced slots whichcooperate in permitting the ferrule portion to be forced over theflanged end of the barrel in securing the cap means thereto, and whichare adapted to interengage the shoulder so as to facilitate theprevention of rocking of the cap means with respect to the tubularbarrel 3 the double pointed hypodermic needle having its rear endproximal the forward face of the diaphragm, a hub having a forward endsecured intermediate the needle ends and having a rear end tubular inconfiguration in substantial concentric relation with respect to theneedle, the tubular rear end of the hub being disposed over the forwardend of the hub support in substantial telescopic and slidingrelationship, the inner face of the tubular rear end of the hub andouter face of the forward end of the support presenting raised andrecessed portions which operate to determine the syringe unarmedposition at which said rear end of the needle is proximal the forwardface of the diaphragm and an unarmed position at which the rear end ofthe needle is forced to penetrate the diaphragm upon application ofdeliberate force to the hub to communicate the lumen of the needle withthe interior of the barrel.

2. The invention in accordance with claim 1 wherein said cap meansinclude internal ribbing integral therewith and in engagement with thediaphragm for creating concentrated pressure points for purposes ofobtaining maximum pressure and sealing between the diaphragm and theflanged end of the barrel.

3. The invention in accordance with claim 1 wherein a plunger rod shieldis disposed around the forward end of the needle and has a closedforward end and an open rear end, said rear end being mounted on theforward end of the needle hub, and the forward end of the shield havingsurfaces cooperable with surfaces of said stopper in providing acoupling means for coupling the shield to said stopper to thereby renderthe shield operable as a plunger rod in facilitating the dispensing ofthe medicament from the barrel.

4. A hypodermic needle, hub and support assembly for attachment to theforward restricted flanged end extending from a forward transverselyextending shoulder of a tubular syringe barrel adapted to contain amedicament said assembly comprising a penetrable diaphragm adapted toseal the forward end of the barrel, resilient cap means for supporting aneedle and securing the diaphragm to the barrel flanged forward endincluding a needle hub support of tubular configuration and a ferruleportion integral therewith for securing the diaphragm to the barrelflanged forward end, the ferrule portion having an integral radiallyinwardly extending annular rib adapted to engage with surfaces of theflanged end of said barrel to thereby affix said cap means thereto, saidferrule portion having a series of spaced slots which cooperate inpermitting the ferrule portion to be forced over the flanged end of thebarrel in securing the cap means thereto, and

which are adapted to interengage the shoulder so as to facilitate theprevention of rocking of the cap mean with respect to the tubular barrela double pointed hypodermic needle having its rear end proximal theforward face of the diaphragm, a hub having a forward end securedintermediate the needle ends and having a rear end tubular inconfiguration in substantial concentric relation with respect to theneedle, the tubular rear end being disposed over the forward end of thehub support in a substantial telescopic and sliding relationship, theinner face of the tubular rear end of the hub and the outer face of theforward end of the support presenting raised and recessed portions whichoperate to determine the syringe unarmed position at which the rear endof the needle is proximal the forward face of the diaphragm and an armedposition at which the rear end of the needle is forced to penetrate thediaphragm upon application of deliberate force to the hub to communicatethe lumen of the needle with the interior of the barrel.

5. The invention in accordance with claim 4 wherein said cap meansinclude internal ribbing integral therewith and in engagement with thediaphragm for creating concentrated pressure points for purposes ofobtaining maximum pressure and sealing between the diaphragm and theflanged end of the barrel.

6. The invention in accordance with claim 4 wherein a plunger rod shieldis disposed around the forward end of the needle and has a closedforward end and an open rear end, said rear end being mounted on theforward end of the needle hub, and the forward end of the shield havingsurfaces cooperable with surfaces of said stopper in providing acoupling means for coupling the shield to said stopper to thereby renderthe shield operable as a plunger rod in facilitating the dispensing ofthe medicament from the barrel.

References Cited UNITED STATES PATENTS 2,828,743 4/1958 Ashkenaz et all28-2l8 2,865,372 12/1958 Miskel l28218 2,957,501 10/1960 Holmes 128-272XR 3,288,320 11/ 1966 Swanson 31539 3,025,988 3/1962 Williams 215412,251,527 8/ 1941 Smith 128272 XR RICHARD A. GAUDET, Primary Examiner.

D. L. BAKER, Assistant Examiner.

